Shen Min Hair Regrowth Claims Targeted In FDA Warning Letter

Biotech Corp.' s Shen Min Activator with Minoxidil and Shen Min Topical solution are new drugs due to their intended use for hair growth and hair loss prevention, FDA says in a July 27 warning letter to the company.

The Glastonbury, Conn.-based dietary supplement marketer introduced Shen Min Activator in food, drug and mass markets this summer and has been selling it at GNC outlets for nearly a year (¹ (Also see "Shen Min Activator Hair Regrowth Serum With Minoxidil Launching In June" - Pink Sheet, 10 May, 1999.)).

Biotech has positioned its products, which contain 1.7% minoxidil, as natural alternatives to the 2% and 5% minoxidil strengths approved by FDA. The firm believes the lower concentration will place the formulation outside of drug regulation.

However, under the agency's 1989 Hair Grower and Hair Loss Prevention Products Final Monograph, OTC remedies are prohibited from making anti-baldness claims without NDA or ANDA approval.

FDA's approval in February 1996 of Pharmacia & Upjohn's Rogaine (2% minoxidil) marked the first OTC hair growth product cleared by the agency. Subsequent ANDAs for private label versions and P&U's NDA for 5% minoxidil (Rogaine Extra Strength) have since been approved.

Labeling claims cited in the warning letter include: "Minoxidil is well known as one of the most successful topical serums available today"; "Retinyl palmitate is scientifically proven and patented to stimulate follicular embryonic activity"; and "Shen Min Activator with Minoxidil features our proprietary Bio-Vector Lipid Complex delivery system....It is controlled-release to ensure continuous stimulation of the follicles."

Directions instruct the user to "apply 15-20 drops directly onto the scalp as needed in the hair loss area."

Based on these claims, FDA says the products "are drugs...and are subject to the final rule covering" hair grower and hair loss prevention products. FDA also says the products are misbranded "because they do not bear adequate directions for the indication noted" and "have not been drug listed as required."

Biotech is required to respond within 15 working days of the letter. The company, which is being represented by the D.C.-based firm Hyman, Phelps & McNamara, is working on a reply.

The company said it is in the process of relabeling the products. Future advertising will be changed as well, and ingredient reformulation also may occur, the firm stated.

Another topical product, Sombra Cosmetic's Sore No More! Natural Pain Relieving Gel, also received a recent FDA warning letter for unsubstantiated "natural" claims.

The July 14 letter says therapeutic claims made by the company include: "Natural Pain Relieving Gel... developed to treat aches, pain, swelling, inflammation, soreness of muscles and joints caused by sports injuries, stiffness, sprains and arthritis."

Brochures claim the product can "relieve pain...get rid of pain the natural way...detoxifies tight sore joints, relieves arthritic pain, muscle soreness, inflammation and gives immediate relief of back pain."

FDA says the claims "establish that the product is a drug...intended to be used in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or any function of the body of man." The gel contains the monographed ingredients menthol 3%, camphor 3% and capsaicin .03% in addition to the inactive ingredients grapefruit seed, green tea and orange peel extracts, Queen of the Prairie extract and yucca extract, for which the claims are made.

In addition, FDA investigators found GMP shortfalls during facility inspections. "These deviations cause your drug products to be adulterated within the meaning of" the FD&C Act, the letter states.

The deviations include failure to test batches of final product lots and failure to "withhold each lot of components from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by a quality control unit."

The Albuquerque, N.M.-based firm has asked FDA for an extension until the end of the month to respond to the warning letter. Sombra said it plans to revise its brochure and has completed some changes to its production processes.